Mavia Farmaceutica Sa
⚠️ Moderate Risk
FEI: 3009054963 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3009054963
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Periferico Calle 7 No 386, Col. Agricola Pantitlan, Iztacalco, Ciudad De Mexico, Ciudad de Mexico, Mexico
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/1/2022 | 60BDA20METHIONINE (ACIDIFIER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2021 | 66FCB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/3/2021 | 56ICY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/1/2020 | 60SDY10MAGALDRATE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2016 | 61MIA30VALPROATE SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/7/2011 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mavia Farmaceutica Sa's FDA import refusal history?
Mavia Farmaceutica Sa (FEI: 3009054963) has 6 FDA import refusal record(s) in our database, spanning from 12/7/2011 to 7/1/2022.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Mavia Farmaceutica Sa's FEI number is 3009054963.
What types of violations has Mavia Farmaceutica Sa received?
Mavia Farmaceutica Sa has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Mavia Farmaceutica Sa come from?
All FDA import refusal data for Mavia Farmaceutica Sa is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.